In the mid-90s, Israeli medicinal chemistry professor Raphael Mechoulam discovered the endocannabinoid system. The professor’s earlier research had already led to the 1964 discovery of THC: the psychoactive ingredient of cannabis.
The endocannabinoid system (ECS) is a set of cell receptors, chemical molecules and enzymes that regulate the human body. This system is crucial in maintaining balance. So, when something gets out of whack inside, the ECS steps in exactly at the time and place it is needed.
However, the ECS can get a little haywire itself, which can actually contribute to the progression of disease. And this is where the benefits of medicinal cannabis can be deployed.
Cannabinoids within the marijuana plant, such as THC and CBD, react with the endocannabinoid system, and bring health and well-being back to the body.
Bringing GPs up to speed
But, this is all new science. And despite the public attention cannabis medicines have recently received, along with the political announcements surrounding its legalisation, a lot of Australian medical practitioners are still unsure, unaware, or are even sceptical, about the plant’s benefits.
That’s why Dr David Caldicott, clinical lead at ANU’s Australian Medicinal Cannabis Observatory, began developing a cannabis medicine course for doctors and nurses back in 2015. And in June last year, the emergency physician delivered his initial medical marijuana workshop in Melbourne.
At the time, Dr Caldicott remarked that the course was designed to bring about clarity to the issue of medicinal cannabis, which has been clouded by political doublespeak, and lumped in with the recreational marijuana debate.
The cupboards are bare
Indeed, in many ways, it’s been patients in Australia that have had the greater awareness regarding the beneficial qualities of medicinal cannabis. And it’s been grassroots campaigners, like Lucy Haslam, that have brought this recognition to the nation’s political arena.
This February marks 24 months since the Turnbull government passed legislation to set up a legal system of cultivation and manufacture of cannabis for medicinal purposes. However, there’s still no domestic medical marijuana products available.
So, many of the estimated 100,000 patients who use illegal cannabis medicines were left scratching their heads in early January, when health minister Greg Hunt announced that regulations will soon be changed to enable Australia to become the biggest exporter of medicinal cannabis in the world.
On the pulse
There are some old school medicinal cannabis advocates that claim medical practitioners are hindering the process of getting cannabis medicines to patients. While others state that the government has taken no steps whatsoever to promote its use amongst GPs.
Sydney Criminal Lawyers® spoke with Dr David Caldicott about where he sits on this issue. The ANU Medical School clinical senior lecturer also gave us a rundown on his much sought-after doctor workshop, and outlines just how far Australia lags behind in regard to medical marijuana.
Firstly, Dr Caldicott, you started presenting your medicinal cannabis course for medical practitioners in June last year. What does it involve?
We’ve been arguing for five years now that the starting point to get anybody interested in prescribing medicinal cannabis is to ensure that they understand the endocannabinoid system, as well as the fact that there is an endocannabinoid system.
So, there are two sections to the course. The first is a very deep introduction to what the endocannabinoid system in the human body is. And then there’s how exogenous cannabinoids – be they synthetics or botanical – can influence that in both health and disease.
And there’s also a certain amount on the politics, regulation and legislation around medicinal cannabis.
What we’ve been doing over the past year is writing more models on things like cannabis and driving, and cannabis and psychosis. These are big questions that keep coming up, which are largely answered, but there’s not actually a lot of independent information in Australia.
So, we have these additional modules that we will be rolling out this year.
There are some other important elements as well. It’s independent. It’s based at the ANU. It is strictly academic. It’s not sponsored either by the pharmaceutical companies, or the producers of cannabis.
It’s incredibly important that practitioners are able to access independent information. Both Big Green and Big Pharma are very interested in influencing the debate through sponsorship.
The statement of the course is that anybody doing it would be as likely to prescribe or not to prescribe cannabis. But, the difference is that those decisions would be based on logic and knowledge, rather than fear and irrational decision-making.
This has been aimed at medical practitioners. So, what’s the response been like?
Embarrassingly positive. I’ve actually had to get independent people to do the assessment elements, because, frankly, it just looks like I’ve filled it in myself.
It’s been overwhelming positive. And I’m not a man to blow my own trumpet. I’m very embarrassed about the comments that people make.
But, the other thing that comes through is surprise. Not just on how much is known about this, but, how far away what is going on in Australia is from what is going on elsewhere in the world.
I don’t think Australian practitioners fully appreciate the gap in practice – between global practice and what is currently being advised in Australia. And it’s clear that disparity is not something that anyone is interested in disabusing at the moment.
If you look at the new cannabis guidances that have been released by the Therapeutic Goods Administration (TGA), there’s very little mention of what anyone else is doing overseas.
It’s not a bad literature review of what’s been published. But, it’s not very useful, as far as practice is concerned.
So, places like the States and Canada have progressed much further ahead of this country?
A country mile ahead of us. In Australia, we’re still dealing with patient numbers in the 100s, despite being 24months post-legislation.
In the United States and Israel, we’re talking about numbers of patients in the tens of thousands. These numbers are expanding. And this would have been halted had there been any problems with those numbers. But, there hasn’t.
The Australian people who are involved in creating policy are insistent that they will not move on this, until there are actual published papers demonstrating efficacy.
And there are statements within the TGA guidances that are just factually incorrect. And there is no information about dosing and dosages.
In an act of great philanthropy, the Israelis very generously handed over their prescribing guidelines to NSW Health and the TGA, when they visited in the autumn last year. And there is no mention of those.
So, despite actually having been given these, they have not been incorporated, or used in any of the guidances being given to Australian practitioners.
The other important thing is, we have this situation in Australia where GPs are being told that they’re not quite good enough to supervise its use with their patients. That it has to be prescribed in conjunction with a specialist.
The specialists who are being asked to recommend this are obviously some of the world’s best specialists in the disease that they’re being consulted on. But, they’d have no more idea about how to prescribe cannabis, than I would about fixing the internal mechanisms of a video recorder.
It seems incredibly strange that the people being asked to prescribe cannabis are people, who are probably a little bit conservative to start with, but also, have no base knowledge.
You shouldn’t assume that because someone is an expert in a disease that they are necessarily an expert in something as new as the endocannabinoid system, and cannabis prescribing.
So, it is a completely misjudged system in terms of how it has been set up. And how it has been implemented.
Some advocates have said that doctors are unwilling to prescribe these medicines.
But, others have pointed out that since the government has announced it was going to legalise medicinal cannabis, and has passed legislation, it hasn’t done anything to encourage doctors to prescribe these medicines.
I agree with both of those statements. I got involved with this back in 2014. And at that stage, there was a bipartisan proposal put forward by members of the Greens, the Labor party, and Liberals to create an office of medicinal cannabis, like everywhere else in the world has.
We’re the only country in the world that has attempted to try this through the standard medical route. And that is probably why it’s such a pig’s breakfast.
But, when I got involved back then, we sat down and thought, “In five years time, what would we need to ensure that this worked safely and well?”
And top of our list was an education program, which is what we wrote and designed, and are now implementing.
New Zealand has now approached us and asked us to run this over there. And they haven’t even implemented there system yet. So, this is where the government should have started. They should have started with, “Let’s talk about this. Let’s do some education.”
My suspicion is that educating practitioners about medical cannabis couldn’t be further away from what they want.
You just mentioned that Australia has decided to go the standard medical route, via the TGA. The TGA has two systems of access: the Special Access Scheme, and its system of Authorised Prescribers.
What do you think about how these systems operate?
I don’t think they’re there to protect patients, or to facilitate access to patients. They do not appear to be patient-centric.
My thing in medicine, as with many of my colleagues, is always to put the patient first. That’s kind of what we are about in medicine.
I absolutely don’t think that was the primary goal in this space. And that’s where this is falling down.
I’ve spoken to medicinal cannabis advocates, who’ve criticised the Authorised Prescribers system, as the few doctors on the list are unable to advertise that they can actually prescribe cannabis medicines. So, patients are unable to find them.
What do you think about this situation?
Well, that’s a long-standing situation in Australia, where prescribers and physicians aren’t allowed to advertise their services.
Because of my position, I would probably get 30 emails a week, asking about medicinal cannabis: who people should talk to, and what they can do.
And it’s very difficult for me to offer any guidance, as I’m certainly not allowed to do that. And I wouldn’t. I often refer them to practitioners in the United States.
So, there’s almost a medical refugee system between Australia and the United States. They have some really, truly, excellent, proper, bona fide medical experts, and paediatricians, who are used to dealing with this. And it is just as easy for them to get medical advice from a Skype call, than it is to try going anywhere in Australia to get that advice.
We’re trying very hard to change that. But, it’s the current scenario.
It will be a lot easier once New Zealand gets their system off the ground. Because people will just need to cross the Tasman to get better advice. And that’s probably what’s going to happen, I fear, long before Australia implements anything that is going to be useful for patients.
The federal government has twice blocked terminally ill patients access to imported products via the category A pathway of the TGA’s Special Access Scheme. This would allow dying patients faster access to imported cannabis medicines.
Currently, these patients must access medicines through the category B pathway, which is much more time consuming.
Why do you think the government is so determined to prevent terminally ill patients from obtaining these medicines through a channel that would provide them with rapid access?
Genuinely, I just don’t know what the motivation is. My own feeling is that there is a desperate attempt to maintain control of the situation.
This is like a cauldron. It’s bubbling at the moment. It’s very hard to identify where both government and the TGA hasn’t taken the wrong step. And they’re just desperately trying to keep control of the situation in Australia.
The latest faux pas was the announcement that Australia could be one of the greatest exporters of medicinal cannabis in the world, without having put their home affairs in order. And this has incensed patient groups.
At the same time as the export announcement, Greg Hunt made some statements along the lines that “there are now no real government barriers at all to accessing medicinal cannabis.” And “it is up to individual doctors.”
This is the most arcane and occult prescribing mechanism for any drug in Australia. That’s just politics. That’s just factually untrue.
The medicinal cannabis legislation was passed in February 2016, and yet, there’s still no domestic product available in Australia.
Why do you think this is the case?
Let’s be clear. This is not policy being introduced by government, because government thinks it’s a great idea. This is policy that is being introduced because patients are demanding it.
The people, like Lucy Haslam, have very powerful voices in the community, and they know what the global situation is. They are infuriated with the sort of approaches in Australia, which aren’t even coming anywhere near the global situation.
There’s no real moral obligation as far as the government is concerned to sort patients out. And what you might expect from this shade of politics is that the language is all about making profit and export.
There are numerous cannabis advocates who are worried that once the legalised system gets up and running, a lot of the black market botanical, and whole plant products, will be lost to synthetic and pharmaceutical ones that aren’t as beneficial.
I could make a much more pragmatic argument. Look at the synthetic products that are on the market, for example Sativex. It can be prescribed in Australia, but for a very limited range of indications. In fact, one. It can be prescribed for muscular spasms associated with multiple sclerosis.
Sativex is grown in a plant. But, then the two components, CBD and THC, are extracted and then reconstituted. A year’s course of that costs $16,000.
The King’s Fund in the United Kingdom has said, “Now, that’s ludicrous. There’s no financial or economic benefit to introduce that to the NHS.”
In contrast, in Israel, they do use botanical product. These are manufactured to good agricultural practices, GAP standards, and good manufacturing practices, GMP standards. They’re not affiliated with Big Pharma. And they’re not isolated or extracted.
So, the course of that medication for any patient for the duration of the course is $100 a person.
And it’s quite clear that you can dose botanical product. The Israelis have not only just produced the equivalent of an asthma inhaler that actually gives a dose of whatever quantity of botanical product that you want, but, just to add insult to injury, they’ve worked out how to 3D print it.
So, this is just miles ahead of what Australia is playing at at the moment.
And the idea that we are giving good information based on what everybody else is doing is rubbish.
The irony is patients don’t believe anything they are being told by authorities in Australia.
And so, what they do is they go on the internet, and they can quite easily compare the experiences of what they are going through, with the experiences of other patients overseas, and work out quite clearly for themselves that they’re largely being lied to.
And lastly, back to your course. What’s the next step with it? And have you approached the government about it?
We’re running it in the ACT in May. We’re running it in New Zealand. We run it for anybody who wants it.
And yes, the government is aware of it. And members who are affiliated to government organisations even attended it in June. But, we never heard back from them.
I don’t think they like it very much because a lot of what we talk about contradicts the current government line, and also the people who work for the medical cannabis advisory group.
Here’s another important feature. If you want to look at some background, the National Academy of Sciences in the United States released a report on medicinal cannabis in January last year.
This is a group of some of the most eminent scientists in the States. They’re appointed academically on the basis of their scientific merit.
And their conclusions were that there is compelling evidence for the use of medicinal cannabis in things like pain. This is the reason why most people in the world use cannabis.
In Australia, we have an advisory group that was politically appointed, which includes people who are representatives of the pharmaceutical industry. And importantly, there are people who aren’t on it. For example, one of the best academics in the world, Lambert Professor Iain McGregor.
But, the people who’ve been involved in campaigning against recreational cannabis are on that group. It’s a politically appointed group. And these are the people who are providing the so-called guidances on how to use medicinal cannabis.
So, there’s a huge imbalance compared to how we are getting together this information in Australia, and how it’s being put together elsewhere in the world.